FDA Adverse Event
Injury
Summary report: N
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
MDR report key: 7924571
·
Received October 1, 2018
Report
- Report Number
- 2031049-2018-00027
- Event Type
- Injury
- Date Received
- October 1, 2018
- Date of Event
- April 27, 2018
- Report Date
- October 1, 2018
- Manufacturer
- TMJ SOLUTIONS, INC.
- Product Code
- LZD
- UDI-DI
- B004TYYNNNNM0
- PMA / PMN Number
- P980052
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS PATIENT RECEIVED BILATERAL IMPLANTS IN (B)(6) 2016. A POST-OPERATIVE CT WAS TAKEN AFTER THE IMPLANT SURGERY AND IT SHOWED THAT THE IMPLANTS WERE MALPOSITIONED. THE IMPLANTS WERE REMOVED IN (B)(6) 2018 AND REVISION COMPONENTS WERE PLACED IN (B)(6) 2018 THAT PROVIDED FOR A DIFFERENT SURGEON-SPECIFIED OCCLUSION.
Description of Event or Problem · 1
THE PATIENT'S TMJ DEVICES WERE REMOVED DUE TO MALPOSITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 764020 | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | TEMPOROMANDIBULAR JOINT IMPLANT | LZD | TMJ SOLUTIONS, INC. | TYY-NNNNM | W36360 | B004TYYNNNNM0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Required Intervention |